Precision GI

FDA 510(k) K231422 · Limaca Medical, Ltd.

Substantially Equivalent

510(k) numberK231422

Submission

Device name
Precision GI
Applicant
Limaca Medical, Ltd.
En Ha'Emeq, IL
Received
May 17, 2023
Decision date
August 28, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FCG – Biopsy Needle
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1075
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FCG

510(k)DeviceApplicantDecision
K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)FCG · Traditional Olympus Medical Systems Corp.10/24/2025SE
K250994ClearTip FNA and FNB TypesFCG · Traditional Finemedix Co., Ltd.08/21/2025SE
K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)FCG · Traditional Cook Ireland, Ltd.07/29/2024SE
K231267ClearTipFCG · Traditional Finemedix Co., Ltd.06/30/2023SE
K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)FCG · Traditional Cook Ireland, Ltd.05/30/2023SE
K212423EndoDrill® Model XFCG · Traditional Bibbinstruments AB03/29/2023SE
K212822Disposable Coaxial Biopsy NeedleFCG · Traditional Suzhou Leapmed Healthcare Corporation07/06/2022SE
K212819Disposable Biopsy Refill NeedleFCG · Traditional Suzhou Leapmed Healthcare Corporation07/06/2022SE
K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…FCG · Traditional Cook Ireland, Ltd.05/20/2021SE
K191472Biopsy NeedleFCG · Traditional Ushare Medical, Inc.01/29/2020SE

Questions and answers

When was Precision GI cleared by the FDA?

Precision GI (K231422) received a 510(k) decision of Substantially Equivalent on August 28, 2023, 103 days after the submission was received.

What is the product code of K231422?

The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.